MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER; NRY

Catalog Number RED68KIT

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text: placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 68 reperfusion catheter (red68) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician made three passes in the target location using the red68.After the pass, while removing the red68 out from the neuron max, the distal end of the red68 fractured and remained in the patient.The physician attempted to remove the fractured piece of the red68 using a snare device; however, the attempt was unsuccessful.The procedure had ended at this point and the patient was referred to neurosurgery.On 10-oct- 2023, additional information was received that the fractured piece of the red68 remained in the patient.

Manufacturer Narrative

Evaluation of the returned red68 confirmed that the catheter was fractured on its distal end.Evaluation revealed stretching near the fractured location and along the distal shaft.The stretching indicates that the device was likely retracted against resistance.If the red68 is retracted against resistance, damage such as stretching and subsequent fracture may occur.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed multiple kinks along the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17987859
• MDR Text Key: 326404913
• Report Number: 3005168196-2023-00475
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948024113
• UDI-Public: 815948024113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RED68KIT
• Device Lot Number: H12231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR